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The Guidelines for EU Official Control Authority Batch Release and EU Official Batch Protocol Review are available only on the EDQM website.  The website contains the most up to date versions as listed below.

​ Download the entire package of procedures and guidelines (updated August 2025)

 

The following table contains access to all documents by clicking on the guideline's name:

 IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS

Guidelines for EU OCABR and OBPR

Document  Title

Last Web Update

 In force from

 

Preface and Notes for use (Back to top)

 18/08/25  x

Administrative Procedure (Back to top)

EU Administrative Procedure for Official Batch Release of Immunological Veterinary Medicinal Products in Application of Article 128 of Regulation (EU) 2019/6

01/06/22

01/07/22

Marketing Information Form (Back to top)

25/01/22

 28/01/22

Product Specific Guidelines for IVMPs eligible for OCABR (Back to top)

Aujeszky's Disease Vaccine (inactivated)

25/01/22

28/01/22

Aujeszky's Disease Vaccine (live)

 25/01/22

 28/01/22

Brucellosis Vaccine (brucella melitensis rev.1 strain and brucella abortus S19 strain) (Live)

25/01/22

28/01/22

Brucellin Preparations

25/01/22

28/01/22
Equine Influenza Vaccine (live)  25/01/22 28/01/22

Equine Influenza Vaccine (inactivated)

 25/01/22

28/01/22

Infectious Bovine Rhinotracheitis Vaccine (inactivated)

 25/01/22

 28/01/22

Infectious Bovine Rhinotracheitis Vaccine (live)

 25/01/22

28/01/22

Newcastle Disease Vaccine (inactivated) Oil Emulsion

 25/01/22

 28/01/22

Newcastle Disease Vaccine (live)

 25/01/22

28/01/22

Rabies Vaccine (inactivated)

 25/01/22

 28/01/22

Rabies Vaccine (live) 

 25/01/22

28/01/22

Swine Erysipelas Vaccine (live)

 25/01/22

28/01/22

Tuberculin Purified Protein Derivative (PPD), Avian

18/08/25

01/09/25

Tuberculin Purified Protein Derivative (PPD), Bovine

18/08/25

01/09/25

Model Protocol Templates for OBPR and OCABR (Back to top)

Inactivated Bacterial Vaccines

 25/01/22

28/01/22

Live Bacterial Vaccines

 25/01/22

28/01/22

Inactivated Viral Vaccines

 25/01/22

28/01/22

Live Viral Vaccines

 25/01/22

28/01/22

Tuberculin PPD/Brucellin Preparations

 25/01/22

28/01/22

General Information (Back to top)

Change Request for Revision of Adopted Guidelines/Procedures for Batch Release (OCABR-Human Network, VBRN)

 25/01/22

x

 

ADDITIONAL DOCUMENTATION
RECENT UPDATES

Revised Guideline (in force from 1 September 2025)
Tuberculin Purified Protein Derivative (PPD), avian

Revised Guideline (in force from 1 September 2025)
Tuberculin Purified Protein Derivative (PPD), bovine

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